TÜRKÇE
ENGLISH
Information
| Code | VTS231 |
| Name | Pharmacovigilance |
| Term | 2024-2025 Academic Year |
| Semester | 3. Semester |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 3 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Lisans Dersi |
| Type | Normal |
| Label | VK Vocational Knowledge Courses E Elective |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Dr. Öğr. Üyesi ZEYNEP ÖZDEMİR KÜTAHYA |
| Course Instructor |
Dr. Öğr. Üyesi ZEYNEP ÖZDEMİR KÜTAHYA
(A Group)
(Ins. in Charge)
|
Course Goal / Objective
It is aimed to train individuals who have sufficient knowledge about the importance of drug safety, pharmacovigilance and veterinary pharmacovigilance-related regulations and practices.
Course Content
The course covers the concepts of pharmacovigilance and regulations and practices related to veterinary pharmacovigilance, and adverse drug reactions.
Course Precondition
None.
Resources
S. Oğuz Kayaalp. Principles of Clinical Pharmacology and Basic Regulations. Pelikan Yayıncılık Ltd. Şti., 2013, 5.Edition. ISBN: 978-605-5270-36-0
Notes
Doğan Fatih. Pharmacovigilance in Veterinary Medicine. Eurasian Journal of Veterinary Sciences, 2011, 27 (1): 19-25.
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Explains the importance of monitoring drug safety in clinical trials and post-authorisation. |
| LO02 | Describes the basic concepts and processes of pharmacovigilance. |
| LO03 | Defines the fields of special interest in the field of pharmacovigilance. |
| LO04 | Expresses adverse drug reactions and related concepts. |
| LO05 | Infers the limitations of preclinical toxicity testing in animals for predicting human toxicity. |
| LO06 | Explains the importance of phase IV studies in terms of toxicity studies in humans. |
| LO07 | Defines reverse drug monitoring methods in pharmacovigilance activities. |
| LO08 | Lists the concepts and objectives of veterinary pharmacovigilance. |
| LO09 | Refers to the most common adverse drug reactions encountered in the veterinary field. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | Bilgi - Kuramsal, Olgusal | Distinguishes animal species and breeds based on their structural (morphological), functional (physiological, biochemical) and behavioral characteristics and whether they can be consumed for food purposes. | |
| PLO02 | Bilgi - Kuramsal, Olgusal | Explains the sources, physical and chemical properties and preparation of drugs. | |
| PLO03 | Bilgi - Kuramsal, Olgusal | Describes the effects and side effects of medications on patients | |
| PLO04 | Bilgi - Kuramsal, Olgusal | Explains the formation mechanisms of animal diseases and their pathological effects on the body. | |
| PLO05 | Bilgi - Kuramsal, Olgusal | It makes efficiency evaluations among animal breeds and, when necessary, carries out selection, hybridization and artificial insemination at a level that can carry out breeding work. | 4 |
| PLO06 | Bilgi - Kuramsal, Olgusal | Disposes of dead animal material, tissue samples, medical and chemical waste appropriately in accordance with international, national laws and regulations. | |
| PLO07 | Beceriler - Bilişsel, Uygulamalı | It determines the correct approach area for the patient by evaluating the examination, operation etc. practices in the clinic according to the topographic anatomy. | |
| PLO08 | Beceriler - Bilişsel, Uygulamalı | Uses biochemical parameters in diagnostic processes by evaluating the information obtained with cause-effect relationships. | |
| PLO09 | Beceriler - Bilişsel, Uygulamalı | Writes prescriptions in accordance with diagnosis and treatment protocols for diseases and poisoning in animals. | 5 |
| PLO10 | Beceriler - Bilişsel, Uygulamalı | Implements necessary measures, including biosecurity, to control infectious diseases. | |
| PLO11 | Beceriler - Bilişsel, Uygulamalı | Performs necropsy to evaluate findings in dead animals, directs tissues to the necessary laboratory according to appropriate storage methods and prepares a report. | 5 |
| PLO12 | Beceriler - Bilişsel, Uygulamalı | Monitors patients in the post-operative process according to the main treatment methods of surgical diseases in animal species. | |
| PLO13 | Beceriler - Bilişsel, Uygulamalı | Applies sedation, anesthesia and pain management methods safely according to animal species. | |
| PLO14 | Beceriler - Bilişsel, Uygulamalı | Correctly applies biosafety principles such as sterilization of clinical and laboratory equipment and clothing. | |
| PLO15 | Beceriler - Bilişsel, Uygulamalı | It regulates the care and feeding protocols according to animal species and supervises the consumption of animal foods produced for human consumption or foods containing animal products in their composition. | |
| PLO16 | Beceriler - Bilişsel, Uygulamalı | Evaluates laboratory results of animal diseases and applies correct diagnosis, prognosis and treatment methods based on the data obtained. | |
| PLO17 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | He/she is conscious of performing his/her profession by being aware of his/her powers and responsibilities. | |
| PLO18 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Examines scientific techniques and methods according to facts related to veterinary services and takes analysis or methodological responsibility for problems. | |
| PLO19 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | It uses adequate technology in the hygienic production, manufacturing, processing, consumption and sales of food by conducting health control of animal food products produced for human consumption. | |
| PLO20 | Yetkinlikler - Öğrenme Yetkinliği | Lists the methods of producing and using scientific knowledge in his/her professional field. | |
| PLO21 | Yetkinlikler - Öğrenme Yetkinliği | Uses updated legislation regarding veterinary services when necessary. | |
| PLO22 | Yetkinlikler - Öğrenme Yetkinliği | Performs an examination appropriate to the case, applying the contribution of imaging methods to diagnosis and radiation safety in accordance with current regulations. | |
| PLO23 | Yetkinlikler - Öğrenme Yetkinliği | Keeps clinical and patient records using proper and scientific methods. | |
| PLO24 | Yetkinlikler - Öğrenme Yetkinliği | By observing the basic principles of medicine, it develops management methods and appropriate management plans for animal production enterprises. | |
| PLO25 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Implement social projects and plans with social awareness, based on professional skills and authority with a computer usage license, advanced computer software. | 2 |
| PLO26 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Works in cooperation with other colleagues by following the world agenda within the framework of professional ethics and deontology rules. | |
| PLO27 | Yetkinlikler - Alana Özgü Yetkinlik | Produces solutions to field-specific problems in line with scientific data/evidence. | |
| PLO28 | Yetkinlikler - Alana Özgü Yetkinlik | He/she has the ethical values of the veterinary profession and defends these values. | |
| PLO29 | Yetkinlikler - Alana Özgü Yetkinlik | Takes appropriate precautions by clinically recognizing zoonosis and notifiable diseases. | 3 |
| PLO30 | Yetkinlikler - Alana Özgü Yetkinlik | Determines the methods of diagnosis, prevention, treatment and operation of diseases in different animal species. | 5 |
| PLO31 | Yetkinlikler - Alana Özgü Yetkinlik | In emergency cases, intervenes in all animals and applies first aid methods. | |
| PLO32 | Yetkinlikler - Alana Özgü Yetkinlik | Makes judgments on animal husbandry principles and breeding by assessing the physical condition, welfare and rearing conditions of domestic animals, communicating appropriately with animal owners and colleagues. | |
| PLO33 | Yetkinlikler - Alana Özgü Yetkinlik | Independently interprets articles and presentations published in other scientific fields related to Veterinary Medicine to maintain professional development and skills. | |
| PLO34 | Yetkinlikler - Alana Özgü Yetkinlik | When necessary, euthanizes animals using appropriate methods and respecting the feelings of animal owners. | |
| PLO35 | Yetkinlikler - Alana Özgü Yetkinlik | By mastering the concepts of occupational safety in terms of the workplace and the personnel working with it, they have the competence to apply and defend it. | 3 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | The importance of monitoring drug safety in clinical trials and post-authorisation. | Lecture notes, books, current articles | Öğretim Yöntemleri: Anlatım |
| 2 | Definition of pharmacovigilance and special fields of interest within the field of pharmacovigilance | Lecture notes, books | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 3 | Activities carried out within the framework of pharmacovigilance, objectives of pharmacovigilance | Lecture notes, current news | Öğretim Yöntemleri: Anlatım, Tartışma |
| 4 | Adverse drug reactions and related concepts | Lecture notes, books | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 5 | Investigation of the causal relationship of adverse drug reactions and adverse events with drug intake | Lecture notes, current articles, current news | Öğretim Yöntemleri: Anlatım, Tartışma |
| 6 | The limitations of preclinical toxicity studies in animals to predict toxicity in humans | Lecture notes, books | Öğretim Yöntemleri: Anlatım |
| 7 | Importance of phase IV studies for toxicity studies in humans | Lecture notes, books, current articles | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 8 | Mid-Term Exam | Question preparation | Ölçme Yöntemleri: Yazılı Sınav |
| 9 | Development of pharmacovigilance systems | Lecture notes, books | Öğretim Yöntemleri: Anlatım |
| 10 | Reverse drug monitoring methods in pharmacovigilance activities | Lecture notes, current news, current articles | Öğretim Yöntemleri: Anlatım, Tartışma |
| 11 | Veterinary pharmacovigilance | Lecture notes | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 12 | Objectives of veterinary pharmacovigilance | Lecture notes, current articles | Öğretim Yöntemleri: Anlatım, Tartışma |
| 13 | Veterinary pharmacovigilance activities in Europe and Turkiye | Lecture notes, current news | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 14 | The most common drug groups causing adverse drug reaction in veterinary medicine | Lecture notes, currents articles, current news | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma |
| 15 | Detection, recording and reporting of drug interactions encountered in drug administration | Lecture notes, books | Öğretim Yöntemleri: Anlatım, Soru-Cevap, Tartışma, Alıştırma ve Uygulama |
| 16 | Term Exams | Question preparation | Ölçme Yöntemleri: Yazılı Sınav |
| 17 | Term Exams | Question preparation | Ölçme Yöntemleri: Yazılı Sınav |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 2 | 28 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 3 | 42 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 2 | 2 |
| Final Exam | 1 | 4 | 4 |
| Total Workload (Hour) | 76 | ||
| Total Workload / 25 (h) | 3,04 | ||
| ECTS | 3 ECTS | ||